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A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT00938262
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : October 8, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Fimasartan, Ketoconazole, Rifampicin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Study Start Date : April 2009
Primary Completion Date : June 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Fimasartan, Ketoconazole, Rifampicin Drug: Fimasartan, Ketoconazole, Rifampicin

Fimasartan (1 day)

Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day)

Rifampicin (9 days) Rifampicin + Fimasartan (1 day)



Outcome Measures

Primary Outcome Measures :
  1. Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2 [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age: 20 - 45 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion Criteria:

  • known allergy to Fimasartan, ketoconazole and rifampicin
  • existing cardiac or hematological diseases
  • existing hepatic and renal diseases
  • existing gastrointestinal diseases
  • acute or chronic diseases which could affect drug absorption or metabolism
  • history of any serious psychological disorder
  • positive drug or alcohol screening
  • smokers of 10 or more cigarettes per day 3 month ago
  • participation in a clinical trial during the last 2 months prior to the start of the study
More Information

Responsible Party: Choi, Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00938262     History of Changes
Other Study ID Numbers: A657-BR-CT-105
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Ketoconazole
Rifampin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers